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There're 2 parts in this interventional study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK112 in combination with AK130 | Experimental |
| |
| AK112 in combination with AK127 | Experimental |
| |
| AK112 in combination with Cadonilimab | Experimental |
| |
| AK112 | Experimental |
| |
| Sintilimab in combination with Bevacizumab biosimilar | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 | Drug | Following a predefined dose and date. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with dose limiting toxicities (DLTs) | DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period. | During the first three weeks. |
| Number of subjects with adverse events (AEs) | AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment. | From the time of informed consent signed through 90 days after the last dose of study drug. |
| Objective Response Rate (ORR) (Phase II) | ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1). | Up to approximately 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Phase Ib) | ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1). | Up to approximately 2 years. |
| Objective Response Rate (ORR) Per mRECIST |
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Inclusion Criteria:
Be able and willing to provide written informed consent.
Have a life expectancy of at least 3 months.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
HCC confirmed by histology/cytology or confirmed by the American Society for the Study of Hepatology (AASLD) clinical diagnostic criteria for hepatocellular carcinoma in patients with cirrhosis.
Phase Ib:
Phase II:
According to RECIST v1.1, there is at least one untreatable measurable lesion, or a measurable lesion with clear imaging progression after local treatment, suitable for repeated and accurate measurement.
Liver function grading Child Pugh Grade A.
Has adequate organ function.
All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
Able to to comply with all requirements of study participation (including all study procedures).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenting Li | Contact | 18116403289 | wenting01.li@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| Cadonilimab | Drug | Following a predefined dose and date. |
|
| AK127 | Drug | Following a predefined dose and date. |
|
| AK130 | Drug | Following a predefined dose and date. |
|
| Sintilimab Injection | Drug | Following the local label direction. |
|
| Bevacizumab biosimilar | Drug | Following the local label direction. |
|
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on mRECIST).
| Up to approximately 2 years. |
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1). | Up to approximately 2 years. |
| Duration of Response (DoR) | The time from first documented evidence of CR or PR until time of first documented disease progression. | Up to approximately 2 years. |
| Progression Free Survival (PFS) | PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. | Up to approximately 2 years. |
| Time to response (TTR) | Time between date of start of treatment until first documented response (CR or PR). | Up to approximately 2 years |
| Overall survival (OS) | OS is defined as the time from first dose until death due to any cause | From baseline until death due to any cause. |
| Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital) | Recruiting | Jinan | Shandong | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |